Associate Director, Global Patient Safety - Ophthalmology

Regeneron Pharmaceuticals • Village of Tarrytown, NY

5d • $176,100 - $287,300 • Onsite

About The Position

The Associate Director of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases. The role includes safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessments. The position is part of a fast-growing, science-driven organization focused on developing medicines for people with serious diseases.

The position is based in Tarrytown, NY; Warren, NJ; or Cambridge, MA, and requires working on site four days per week. Travel may be required up to 25%.

Requirements

• Master's, PhD, or PharmD degree; a terminal degree is preferred.
• At least 9 years of relevant risk management experience in the pharmaceutical or biotechnology industry or at a health authority.
• Previous safety or relevant clinical experience in the pharmaceutical industry; typically, at least 8–10 or more years of risk management or relevant clinical experience in the pharmaceutical or biotechnology industry or at a health authority.
• Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities in clinical trial and post-marketing environments.
• Ability to work with a safety system database for medical case review and simple queries.
• Proactive and self-disciplined approach, with the ability to meet deliverables, use time effectively, and prioritize.
• Ability to communicate safety findings effectively, both verbally and in writing.

Nice To Haves

• Clinical and/or industry experience in the therapeutic area of interest.

Responsibilities

• Complete signal detection activities in line with approved safety surveillance plans.
• Perform signal evaluations for identified signals and author safety evaluation reports.
• Manage preparation and review of safety documents, including DSURs, PSURs, RMPs, and responses to health authority or other queries.
• Prepare and deliver presentations at Signal Management Team (SMT) meetings.
• Participate in clinical study team meetings for assigned compounds.
• Participate in other risk management activities as appropriate for assigned compounds.
• Represent GPS on cross-functional teams as needed, including the Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), and teams with members external to Regeneron.
• Serve as a resource for medical review of assigned compounds.
• Participate in process improvement initiatives, including development and maintenance of relevant SOPs, WIs, and supporting documents.

Benefits

• Annual bonuses or other incentive plans may be available.
• Equity awards may be available.
• Pension or retirement benefits may be available.
• 401(k) company match may be available.
• Health and wellness programs may be available.
• Fitness centers may be available.
• Medical, dental, vision, life, and disability insurance benefits may be available.
• Paid time off may be available.
• Family support benefits may be available.

What This Job Offers

• Job Type: Full-time
• Career Level: Director